What it's for (Indications)
- Long-term (maintenance) therapy for preventing or decreasing wheezing and difficulty in breathing due to asthma, including exercise-induced bronchospasm.
- Also indicated for ongoing lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), which encompasses chronic bronchitis and emphysema.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | This medication is for oral inhalation only. For adult and adolescent patients aged 12 years and older, the typical dosage is 2 inhalations twice daily. Available strengths include fluticasone propionate/salmeterol HFA 45 mcg/21 mcg, 115 mcg/21 mcg, or 230 mcg/21 mcg. The starting dosage should be determined based on the severity of asthma. After inhalation, patients should rinse their mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Before using for the first time, the inhaler should be primed by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. If the inhaler has not been used for more than 4 weeks or has been dropped, it should be re-primed by releasing 2 sprays into the air away from the face. |
Safety & Warnings
Common Side Effects
- Common side effects include oral candidiasis (fungal infection of the mouth/oropharyngeal candidiasis), hoarseness (dysphonia), headache, throat irritation, palpitations, tremor (involuntary shaking), irregular heartbeats, myalgia (muscle pain), arthralgia (joint pain), muscle cramps, dizziness, nausea, vomiting, and upper respiratory tract infection or inflammation.
- Hypersensitivity reactions may also occur.
Serious Warnings
- Black Box Warning: Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol (an active ingredient in this product), increase the risk of asthma-related death. Data from a large, randomized, placebo-controlled US study demonstrated an increased risk of asthma-related deaths in patients receiving salmeterol. These findings are considered a class effect of LABAs. Therefore, this product should only be used as additional therapy for patients with asthma who are currently receiving, but are not adequately controlled on, a long-term asthma control medication, such as an inhaled corticosteroid. This product is not indicated for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
- This medication is not indicated for the primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.
- Patients should be monitored for serious asthma-related events, including hospitalizations, intubations, and death.
- Caution is advised in individuals with pulmonary tuberculosis, several cardiovascular disorders, hypokalemia (decreased blood potassium), thyrotoxicosis (excessive thyroid hormone), and in cases of paradoxical bronchospasm (unexpected narrowing of the respiratory pathway).
- Long-term treatment may lead to decreased adrenal gland function (hypercorticism and adrenal suppression) and systemic corticosteroid effects, including immunosuppression and an increased risk of infections, reduction in bone mineral density, growth effects in children (height should be monitored regularly), and ocular effects such as glaucoma and cataracts.
- Patients with COPD are at an increased risk of pneumonia.
- For pregnant females, it should only be used when clinically necessary, and the potential risks and benefits should be discussed with a doctor or pharmacist.
- For lactating mothers, the passage of this medicine into breast milk is unknown, and its use should be under a doctor's prescription.
- Consider additional steroid therapy during periods of stress or surgery.
- To reduce the risk of oropharyngeal candidiasis, patients should rinse their mouth with water without swallowing after each inhalation.
How it Works (Mechanism of Action)
This medication contains two active components: fluticasone propionate and salmeterol. Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity, exhibiting high binding affinity for the human glucocorticoid receptor. Salmeterol is a long-acting beta2-adrenergic agonist (LABA) that works by relaxing muscles around the airways, causing them to open and facilitating easier breathing. These two drugs represent different classes of medications that exert distinct effects on clinical, physiological, and inflammatory indices of asthma.